The present invention relates to a method for filling containers with fresh blood components such as, e.g., serum-eye drops, platelet-rich plasma, etc. . . .
To date, fresh blood components, in particular autologous blood components, are generally introduced into suitable containers, of the type of micro test tubes having relative closing caps, insulin syringes and vials, from which an operator then withdraws the desired quantity and introduces this individually inside a plurality of containers intended for use on the patient.
Since these operations involve transferring blood components from one container to another, and therefore their passage into the external environment, they must of course be performed in a sterile environment. Furthermore, the removal and storage of these containers does not guarantee their adequate storage and administration to the patient in a safe way, with loss of sterility and consequent risks of contamination of the product which considerably increases the risks of infection for the patient.
The preparation of such containers must be performed by trained medical or nursing staff inasmuch as the therapeutic efficacy of the product is strongly affected by the standards and procedures used to perform the above phases.
It follows, therefore, that this known method for the preparation of containers with fresh autologous blood components besides being complex to make is also unsafe from the health point of view and is therefore not feasible on the basis of the regulations in force. In fact, the correct performance of the operations described above is closely related to the ability of the personnel in charge and to the environment in which they are performed. These factors appear to be extremely limiting, inasmuch as they expose the preparation of the containers with autologous blood components to various risks.
Another known method for the preparation of containers with autologous blood components includes the filling of a duct (dialysis tubing) made of plastic material and the closure of this duct, e.g. by sealing, at a plurality of zones arranged in succession the one to the other and spaced apart the one from the other, so as to form a plurality of closed units.
These units are then opened, before their use, by cutting one of their respective ends, e.g. using scissors, in such a way as to make their content available for use.
This second method for the preparation of units containing platelet concentrate has a number of drawbacks.
More in particular, the units of known type are not easy and safe to use and do not permit compliance with the hygienic-health standards required by applicable laws as well as by blood product certification bodies.
In fact, the opening of these units by means of scissors or the like, entails that on the cutting zone of such scissors residues remain of the organic material contained in the relative unit, with the consequent risk of contaminating the contents of the other units subsequently cut using the same scissors.
This obviously creates the risk of the platelet contents of the units cut by means of previously-used scissors becoming polluted by the residues left on the scissors themselves, thus compromising their therapeutic properties and above all significantly increasing the risk of developing secondary infections in already immunosuppressed patients and in an already-compromised organ.